Applications for clinical trials and related studies
Summary
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arc is making a major new investment in clinical trials and related research
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All proposals for clinical trials and related research will now be directed via national strategic research groups
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The role of individual investigators will be protected consistent with acceptance that all studies must be part of a national agreed strategy
- The existing clinical trials funding stream is closed to new projects
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Proposals for clinical trials will also no longer be accepted as routine project grants
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There will be increased opportunities for research ‘add ons’ to clinical trials and related studies
Outline of scheme
A new approach to the funding of clinical trials and related studies has recently been launched by arc. In future, all proposals to undertake clinical trials will be considered only as part of an overall strategy by one of seven specifically established Clinical Studies Groups. These groups are being tasked to consider their specific area and produce a portfolio of studies which will include some, or all, of:
- Literature reviews and meta-analyses
- Pilot and feasibility studies for recruitment, biomarkers and outcome assessments
- Formal randomised clinical trials
- Other well designed clinical studies
Each of the Groups’ portfolios will be developed after extensive and continuing collaboration and involvement of all relevant stakeholders and will be subject to external review. The individual studies, both pilot and full investigations, will be subject to open competition and peer review.
The programmes developed will be compliant with the role of the Local Research Network programme in England (and parallel schemes in the other UK countries) to allow access to NHS (and equivalent bodies in the other countries) support costs and resources for research. Included in the overall programme is provision for assistance and support in study design as well as ethical and governance issues. The programmes will also, where appropriate, have industrial partners.
Clinical Studies Groups
A Group Leader has recently been appointed to each Clinical Studies Group for an initial 3 year term, who will be responsible for the Group activities and ensuring that all interests are represented. The groups and the leaders are as follows:
The working methods of each group will be developed in the last quarter of 2007 and may include sub-groups related, for example, to specific disorders (say, scleroderma within auto-immune rheumatic disorders) or to specific types of interventions (say, surgical approaches in osteoarthritis).
Role for individual investigators
The central concept behind this new strategy is that clinical trial and related research should be planned as part of a national agreed strategy, and not be subject to the vagaries of individually submitted applications. However, the role of individual investigators in ensuring the success of the scheme needs to be recognised.
- Participation in strategic development: As the Group plans evolve, the group leaders will need to ensure that all proposals from any potential investigator are considered as part of any final agreed strategy. In that sense, this should be considered a part of the peer review process in terms of agreement of the value of the proposal.
- Ownership of the agreed proposal: It is a condition of UKCRN funding that all proposals are subject to open competition. However, it is anticipated that the process will evolve and each Group will be responsible for allocating leadership of the projects it supports. It would be anticipated that those who are responsible for suggesting a study would be in the strongest position (should they wish) to lead on it. However, much of the resulting research will be collaborative and may represent an amalgam of two or more similarly focussed objectives.
- Priority for funding: arc is substantially increasing its investment in this area of research from approximately £2 million per annum currently to £5 million. Taking account of the additional resources from UKCRN, the consequence will be a major increase in support and it is anticipated that there will be sufficient resources available for all studies accepted on strategic and scientific quality grounds.
Timetable for implementation
From July 2007, no proposals for clinical trials will be considered for funding by arc’s project grant route and any such proposals received will be directed towards the new Groups.
The existing Clinical Trials programme will also not accept any new trials for funding or any extensions or substantive additions to currently funded trials. Any such request will be passed to the new Groups for consideration as part of the overall strategy. Similarly, where proposals are for other clinical based studies directed towards the evaluation of both new and existing therapies, these will also be passed to the Groups.
It is accepted that there will be delays during the early months whilst the systems are put in place, but it is aimed that the portfolios will begin to merge during Spring 2008 and funding of pilot and feasibility studies will commence by Summer 2008. Approval of full trials could be achieved as early as Summer 2008 depending on the individual Group’s plans and priorities. This timetable needs to be considered alongside the current situation where, on average, it takes 24 months from first receipt of a clinical trial proposal to approval of funding.
arc funding of clinical data and sample collections
As part of this new initiative, it is envisaged that the patients recruited for studies in any disease area could usefully provide the base material for a clinical data collection and indeed a collection of samples such as DNA, serum, synovial fluids and related samples. Indeed arc will encourage Groups to capitalise on the clinical studies it supports to develop such resources for the wider research benefit of the community in that area. One advantage of linking this activity into the clinical trials programme is that NHS resources can be utilised in the establishment of the collections.
As a consequence, arc will not consider any request for separate funding for a clinical trial or sample collection unless it is not considered to be of strategic importance and could not be achieved as part of the Clinical Studies Groups’ strategic goals. This policy will result in a centralised approach to such activities which is both cost efficient and equitable.
Further information for potential grant applicants for Clinical Studies
Clinical studies submitted as project grants will be directed to the new scheme, although other studies will still be eligible for project grant funding. In general, all clinical trials will be directed to the new Clinical Studies Groups.
If you are not sure whether your proposal should be submitted for a traditional project grant or should be considered by one of the new groups, please send a brief summary of your proposal to Mike Patnick – m.patnick@arc.org.uk.
